Trial Outcomes & Findings for Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease (NCT NCT00829738)

Results Overview

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

Recruitment status

COMPLETED

Target enrollment

4188 participants

Primary outcome timeframe

14 days

Results posted on

2012-05-08

Participant Flow

All patients were evaluated, missing values were not imputed.

Participant milestones

Participant milestones
Measure	Pantoprazole All patients enrolled
Overall Study STARTED	4188
Overall Study COMPLETED	4180
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pantoprazole n=4188 Participants All patients enrolled
Age Continuous	55.3 years STANDARD_DEVIATION 14.82 • n=5 Participants
Sex/Gender, Customized Female	47.6 percentage of participants n=5 Participants
Sex/Gender, Customized Male	52.0 percentage of participants n=5 Participants
Sex/Gender, Customized Missing data	0.4 percentage of participants n=5 Participants
Nicotine use Smoker	36.7 percentage of participants n=5 Participants
Nicotine use Non-smoker	62.8 percentage of participants n=5 Participants
Nicotine use Missing data	0.4 percentage of participants n=5 Participants
Alcohol use Daily	21.9 percentage of participants n=5 Participants
Alcohol use Not daily	77.4 percentage of participants n=5 Participants
Alcohol use Missing data	0.6 percentage of participants n=5 Participants
Drug abuse Drug abuse	3.6 percentage of participants n=5 Participants
Drug abuse No drug abuse	95.5 percentage of participants n=5 Participants
Drug abuse Missing data	0.9 percentage of participants n=5 Participants
Indication for prescription of pantoprazole Long-term therapy and/or relapse prophylaxis	39.8 percentage of participants n=5 Participants
Indication for prescription of pantoprazole Acute reflux oesophagitis	57.2 percentage of participants n=5 Participants
Indication for prescription of pantoprazole Missing data	3.0 percentage of participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

Outcome measures

Outcome measures
Measure	Pantoprazole n=4155 Participants All patients with valid values at first and last visit
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn Start of therapy	3.10 units on a scale Standard Deviation 0.80
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn End of study	1.36 units on a scale Standard Deviation 0.52

PRIMARY outcome

Timeframe: 14 days

Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

Outcome measures

Outcome measures
Measure	Pantoprazole n=4155 Participants All patients with valid values at first and last visit
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation Start of therapy	2.75 units on a scale Standard Deviation 0.89
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation End of study	1.30 units on a scale Standard Deviation 0.50

PRIMARY outcome

Timeframe: 14 days

Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

Outcome measures

Outcome measures
Measure	Pantoprazole n=4127 Participants All patients with valid values at first and last visit
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing Start of therapy	1.87 units on a scale Standard Deviation 0.93
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing End of study	1.06 units on a scale Standard Deviation 0.24

PRIMARY outcome

Timeframe: 14 days

Population: Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Outcome measures

Outcome measures
Measure	Pantoprazole n=4188 Participants All patients with valid values at first and last visit
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms Good	19.2 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms Excellent	79.0 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms Satisfactory	1.2 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms Not satisfactory	0.1 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms Missing data	0.5 percentage of participants

SECONDARY outcome

Timeframe: 14 days

Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

Outcome measures

Outcome measures
Measure	Pantoprazole n=4129 Participants All patients with valid values at first and last visit
Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain Start of therapy	2.21 units on a scale Standard Deviation 0.90
Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain End of study	1.17 units on a scale Standard Deviation 0.40

SECONDARY outcome

Timeframe: 14 days

Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

Outcome measures

Outcome measures
Measure	Pantoprazole n=4122 Participants All patients with valid values at first and last visit
Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness Start of therapy	2.35 units on a scale Standard Deviation 0.95
Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness End of study	1.26 units on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: 14 days

Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

Outcome measures

Outcome measures
Measure	Pantoprazole n=4055 Participants All patients with valid values at first and last visit
Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea Start of therapy	1.75 units on a scale Standard Deviation 0.82
Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea End of study	1.07 units on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: 14 days

Population: Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Outcome measures

Outcome measures
Measure	Pantoprazole n=4188 Participants All patients with valid values at first and last visit
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms Excellent	67.3 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms Good	26.0 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms Satisfactory	2.2 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms Not satisfactory	0.4 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms Missing data	4.2 percentage of participants

SECONDARY outcome

Timeframe: 14 days

Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

Outcome measures

Outcome measures
Measure	Pantoprazole n=4099 Participants All patients with valid values at first and last visit
Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain Start of therapy	1.39 units on a scale Standard Deviation 0.70
Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain End of study	1.06 units on a scale Standard Deviation 0.25

SECONDARY outcome

Timeframe: 14 days

Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

Outcome measures

Outcome measures
Measure	Pantoprazole n=4087 Participants All patients with valid values at first and last visit
Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea Start of therapy	1.26 units on a scale Standard Deviation 0.58
Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea End of study	1.05 units on a scale Standard Deviation 0.25

SECONDARY outcome

Timeframe: 14 days

Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

Outcome measures

Outcome measures
Measure	Pantoprazole n=4090 Participants All patients with valid values at first and last visit
Irritable Bowel Syndrome: Assessment of the Severity of Constipation Start of therapy	1.19 units on a scale Standard Deviation 0.53
Irritable Bowel Syndrome: Assessment of the Severity of Constipation End of study	1.06 units on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: 14 days

Population: Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Outcome measures

Outcome measures
Measure	Pantoprazole n=4188 Participants All patients with valid values at first and last visit
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome Excellent	53.9 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome Good	25.1 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome Satisfactory	5.9 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome Not satisfactory	0.7 percentage of participants
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome Missing data	14.4 percentage of participants

SECONDARY outcome

Timeframe: 14 days

Population: Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat

Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Outcome measures

Outcome measures
Measure	Pantoprazole n=4188 Participants All patients with valid values at first and last visit
Assessment of the Tolerability of Pantoprazole at Final Visit Satisfactory	0.5 percentage of participants
Assessment of the Tolerability of Pantoprazole at Final Visit Excellent	84.5 percentage of participants
Assessment of the Tolerability of Pantoprazole at Final Visit Good	14.3 percentage of participants
Assessment of the Tolerability of Pantoprazole at Final Visit Not satisfactory	0.02 percentage of participants
Assessment of the Tolerability of Pantoprazole at Final Visit Missing data	0.7 percentage of participants

Adverse Events

Pantoprazole

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pantoprazole n=4188 participants at risk Patients included and treated with at least one application of pantoprazole
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.02% 1/4188 • Number of events 1 • From first until last visit
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.02% 1/4188 • Number of events 1 • From first until last visit

Other adverse events

Other adverse events
Measure	Pantoprazole n=4188 participants at risk Patients included and treated with at least one application of pantoprazole
Gastrointestinal disorders Diarrhoea	0.02% 1/4188 • Number of events 1 • From first until last visit
Gastrointestinal disorders Dyspepsia	0.02% 1/4188 • Number of events 1 • From first until last visit
Gastrointestinal disorders Nausea	0.02% 1/4188 • Number of events 1 • From first until last visit
Investigations Alanine aminotransferase increased	0.02% 1/4188 • Number of events 1 • From first until last visit
Nervous system disorders Dizziness	0.02% 1/4188 • Number of events 1 • From first until last visit

Additional Information

Medical Responsible

Nycomed Deutschland GmbH

Phone: +49 7531 3666 0

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place